3D/5D Viewer is a software application for the display and 3D visualization of ultrasound volume data derived from ultrasound system. It is designed to allow the user to observe images and perform analysis using the ultrasound volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, editing, measuring and storing of volume data. Typical users of this system are trained professionals, including physicians, nurses. and technicians.

Device Description

3D/5D Viewer is a standalone software product, which can be installed on a laptop/PC with Microsoft Windows XP and 7. It allows the user to use their computer to review, analyze, edit, and measure the volume data exported from ultrasound equipment via storage media such as a USB drive. As the 3D/5D Viewer software reads 3D volume data, the users can review test results of patients more quickly and easily. This function allows them to check 3D image results without using an ultrasound system, which helps them conduct more tests with the ultrasound system.

Primary operating functions are:

Display and editing of Volume data sets
Data storage (image, volume data)
Support simple Caliper (distance, Ellipse, 3 Distance volume)

Some functions that it need to USB dongle are:

HDVI
5D Heart

AI/ML Overview

Based on the provided text, the "3D/5D Viewer" is a software application for displaying and visualizing ultrasound volume data. The document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to predicate devices rather than providing new clinical performance data with specific acceptance criteria as one might find for a novel diagnostic AI.

Therefore, the study proving the device meets acceptance criteria in the sense of a new diagnostic AI with performance metrics (like sensitivity, specificity, or AUC) is not present in this document. The "acceptance criteria" here are instead focused on demonstrating substantial equivalence to already marketed devices, primarily by comparing technological characteristics and functionality.

Here's a breakdown based on your request, highlighting what is and isn't available in the provided text:

Study Information Pertaining to Device Performance (as would be expected for a novel AI, but not found here):

1. A table of acceptance criteria and the reported device performance: Not applicable/Not found. The document does not describe specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the 3D/5D Viewer that would typically have acceptance criteria. Its acceptance is based on substantial equivalence.
2. Sample size used for the test set and the data provenance: Not applicable/Not found. As no clinical performance study was conducted for this submission, there's no test set or related data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not found.
4. Adjudication method for the test set: Not applicable/Not found.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/Not found. The device is a viewer/analysis tool, not an AI to assist human readers in diagnosis. No such study was conducted or presented.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not found. The device is a viewer for human use, not a standalone diagnostic algorithm.
7. The type of ground truth used: Not applicable/Not found.
8. The sample size for the training set: Not applicable/Not found. The document does not describe the device as an AI trained on a dataset. It's a software application for visualization and analysis of existing ultrasound data.
9. How the ground truth for the training set was established: Not applicable/Not found.

What is present regarding "acceptance criteria" through the lens of Substantial Equivalence:

The primary "acceptance criteria" for this 510(k) submission are based on demonstrating that the "3D/5D Viewer" is substantially equivalent to legally marketed predicate devices. This is shown by comparing its technological characteristics and intended use.

1. A table of (Technological) Acceptance Criteria and the Reported Device Performance (Comparison to Predicates):

The table provided outlines the functional "acceptance criteria" by comparing the subject device's features to those of its predicates. Its "performance" in this context is its ability to match or exceed the functionalities of the predicates.

Feature	Subject Device (3D/5D Viewer)	The primary predicate devices (SonoView ProTM K031886)	The predicate devices (WS80A K143089)
Computer Operating System
- Windows XP, 7	Yes	Yes	Not applicable
Opening and saving files
- Type of file
*.mvl	Yes	Yes	Yes
*.sty	Yes	No	Yes
Functionality
- MPR
Slub 3D	Yes	Yes	Yes
Accept ROI	Yes	Yes	Yes
FAD	Yes	No	Yes
Curved ROI	Yes	No	Yes
- Mirror View	Yes	Yes	Yes
- MagiCut
Smooth Cut	Yes	No	Yes
- Volume Slice	Yes	Yes	Yes
- MSV	Yes	Yes	Yes
- Oblique View	Yes	Yes	Yes
- Volume CT	Yes	Yes	Yes
- VOCAL	Yes	Yes	Yes
- XI VOCAL	Yes	Yes	Yes
- Cine View
3D Cine	Yes	Yes	Yes
4D Cine	Yes	Yes	Yes
- 5D Functions
5D NT	Yes	No	Yes
5D CNS	Yes	No	Yes
5D Follicle	Yes	No	Yes
5D LB	Yes	No	Yes
5D Heart	Yes	No	Yes
- Measurement
Distance	Yes	No	Yes
Ellipse	Yes	No	Yes
3 Distance Volume	Yes	No	Yes
- Render Setup functions
Realistic Vue	Yes	No	Yes
VSI	Yes	No	Yes
- Post Processing functions
Post Gain	Yes	No	Yes
Clear SFVI	Yes	No	Yes
Detailed SFVI	Yes	No	Yes
HDVI	Yes	No	Yes
- Chroma map function	Yes	Yes	Yes

Notes on the "Study" (in the context of Substantial Equivalence):

Sample size and Data Provenance: Not applicable. The "study" is a comparison of technical specifications, not a clinical trial with patient data.
Ground Truth Establishment/Experts: Not applicable. The "ground truth" for substantial equivalence is the functionality of the predicate devices already on the market.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not conducted. The document explicitly states: "The subject of this submission, 3D/5D Viewer, did not require clinical studies to support substantial equivalence."
Standalone Performance: The device is a "standalone software product" in that it can be installed on a laptop/PC and functions independently of the ultrasound system for viewing and analysis. However, this is not a "standalone AI algorithm performance" in the diagnostic sense.
Type of Ground Truth (for the purpose of the 510(k)): The "ground truth" for this regulatory submission is the established safety and effectiveness of the identified predicate devices (SonoView Pro™ K031886 and WS80A Diagnostic Ultrasound System K143089). The applicant demonstrates that its device performs equivalently or better in terms of features and functionality relevant to its intended use.
Training Set Sample Size and Ground Truth for Training: Not applicable. The device is not described as a machine learning/AI model that requires training data and ground truth labels in the typical sense. It is a software application providing visualization and analysis tools.

In summary, this document is a regulatory submission demonstrating substantial equivalence through a comparison of technical features and intended use, rather than a clinical performance study with defined acceptance criteria for diagnostic accuracy or efficacy.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2015

Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street. NW BUFFALO MN 55313

Re: K151808

Trade/Device Name: 3D/5D Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 1, 2015 Received: July 2, 2015

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151808

Device Name 3D/5D Viewer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

1. Submitter's Information:

SAMSUNG MEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea

Contact Person: Jiyoung, Kim Regulatory Affairs Manager

Telephone: 82.2.2.2194.1299 Facsimile: 82.2.556.3974

Data Prepared: April 27, 2015

2. Name of the device:

Common/Usual Name: Picture Archiving Communications System Proprietary Name: 3D/5D Viewer Classification Names: FR Number Product Code Picture Archiving Communications System 892.2050 LLZ

3. Identification of the predicate or legally marketed device:

SonoView Pro™ (K031886) ।
WS80A Diagnostic Ultrasound System (K143089) -

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4. Device Description:

Primary operating functions are:

· Display and editing of Volume data sets
· Data storage (image, volume data)
· Support simple Caliper (distance, Ellipse, 3 Distance volume)

Some functions that it need to USB dongle are:

· HDVI
· 5D Heart

5. Intended Uses:

3D/5D Viewer is a software application for the display and 3D visualization of Ultrasound volume data derived from Ultrasound system. It is designed to allow the user to observe images and perform analysis using the volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, analyzing, editing, measuring and storing of volume data.

6. Technological Characteristics:

3D/5D Viewer is substantially equivalent with respect to safety, effectiveness, and functionality to the SonoView Pro™ (K031886) and WS80A Diagnostic Ultrasound System (K143089).

The device is a software application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets volume data being displayed. It is designed to allow the user to observe images and perform analysis using the volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, analyzing, editing, measuring and storing of volume data.

These are described in detail in the technological characteristics comparison table as below.

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--	---------------------------------------------------------------------------	--	--	--

Feature	Subject Device	The primary predicate devices	The predicate devices
	3D/5D Viewer	SonoView ProTM	WS80A
		(K031886)	(K143089)
Computer Operating System
- Windows XP, 7	Yes	Yes	Not applicable
Opening and saving files
- Type of file
*.mvl	Yes	Yes	Yes
*.sty	Yes	No	Yes
Functionality
- MPR
Slub 3D	Yes	Yes	Yes
Accept ROI	Yes	Yes	Yes
FAD	Yes	No	Yes
Curved ROI	Yes	No	Yes
- Mirror View	Yes	Yes	Yes
- MagiCut
Smooth Cut	Yes	No	Yes
- Volume Slice	Yes	Yes	Yes
- MSV	Yes	Yes	Yes
- Oblique View	Yes	Yes	Yes
- Volume CT	Yes	Yes	Yes
- VOCAL	Yes	Yes	Yes
- XI VOCAL	Yes	Yes	Yes
- Cine View
3D Cine	Yes	Yes	Yes
4D Cine	Yes	Yes	Yes
- 5D Functions
5D NT	Yes	No	Yes
5D CNS	Yes	No	Yes
5D Follicle	Yes	No	Yes
5D LB	Yes	No	Yes
5D Heart	Yes	No	Yes
- Measurement
Distance	Yes	No	Yes
Ellipse	Yes	No	Yes
3 Distance Volume	Yes	No	Yes
- Render Setup functions
Realistic Vue	Yes	No	Yes
VSI	Yes	No	Yes
- Post Processing functions
Post Gain	Yes	No	Yes
Clear SFVI	Yes	No	Yes
Detailed SFVI	Yes	No	Yes
HDVI	Yes	No	Yes
- Chroma map function	Yes	Yes	Yes

7. A brief discussion of the non-clinical and clinical tests conducted on the subject device

The device has been evaluated to conform to applicable voluntary standards.

IEC 62304 Medical device software Software life-cycle processes
ISO 14971 Medical devices Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
HIPAA COMPLIANCE 3D/5D Viewer is in compliance with the Health Insurance Portability and

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Accountability Act of 1996 (HIPAA).

SAMSUNG MEDISON Software Development Procedure (DXQ2-0035K)
Summary of Clinical Tests:

Not applicable. The subject of this submission, 3D/5D Viewer, did not require clinical studies to support substantial equivalence.

8. Conclusion

SAMSUNG MEDISON CO., LTD. considers the 3D/5D Viewer to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

The 510(k) Pre-Market Notification for the 3D/5D Viewer contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.

END of 510(K) Summary

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).